Kornimate/medical-research-clean huggingface dataset:
surveillance and proactive intervention for dialysis access

Conditions: Renal Failure; Arteriovenous Fistula

Summary: newly formed dialysis fistulae can often fail, and failure is usually due to narrowing of the blood vessels. methods of detecting narrowing are available and, more importantly, can detect narrowings before a fistula fails. it is not known whether treating these narrowings will actually improve fistula survival or if the majority can be left alone. we wish to see if we can detect such narrowings with ultrasound scanning and if early detection and treatment improves patient outcomes.


Eligibility criteria:
inclusion criteria: 1. incident patients referred to vascular or transplant surgery departments for primary av fistula formation for haemodialysis access. 2. ability to give informed written consent 3. aged over 18 at time of referral exclusion criteria: 1. inability to give informed written consent 2. aged under 18 at time of referral 3. inability to attend follow-up appointments specific exclusion; 1. previous arteriovenous access procedures in target limb 2. unsuitable for upper limb radiocephalic or brachiocephalic avf formation 3. known thrombophilic or thrombotic pathology

Keywords: arteriovenous fistula surveillance arterial stenosis venous stenosis
comparing suprainguinal fascia iliaca block with erector spinae plane block in hip and proximal femur surgery

Conditions: Postoperative Pain; Femur Fracture; Regional Anesthesia

Summary: most hip fractures occur in the elderly population. opioid-related respiratory depression is more common in the elderly population but can cause severe brain damage or death. reducing the amount of opioids administered before, during and after surgery by adding a regional block may increase the postoperative quality of recovery, reduce chronic pain syndromes, and may potentially facilitate the participation of patients in rehabilitation. despite their potential advantages, peripheral nerve blocks are still not widely used in people with hip fractures. the primary objective of this study is to compare patients' postoperative pain scores and opioid consumption.


Eligibility criteria:
inclusion criteria: * patients over 18 years old, undergoing hip fracture surgery exclusion criteria: * patients with solid organ dysfunction, chronic opioid or corticosteroid use, bleeding diathesis, patients receiving inpatient medication, patients with psychiatric disorders and patients who cannot be contacted after surgery.

Keywords: postoperative pain lumbar erector spinae plane block fascia iliaca block
relmacabtagene autoleucel in patients with lbcl

Conditions: Large B-cell Lymphoma

Summary: to evaluate the efficacy and safety of relmacabtagene autoleucel for the treatment of adult patients with relapsed or refractory (r/r) large b-cell lymphoma (lbcl) in real-world

this is a post-marketing, multicenter, observational real-world study, including prospective and retrospective studies. the purpose of this study is to collect efficacy and safety data over a 6-month period following treatment of adult patients with r/r lbcl with relmacabtagene autoleucel. the treating physicians in the study will determine the most appropriate diagnostic and therapeutic regimen for their patients based on clinical practice.there will be no therapeutic intervention as a result of this study. there will be no subgroups of any kind in this study, and subgroup analyses will be performed based on the actual data collected during the analysis.

Eligibility criteria:
inclusion criteria: 1. adult patients with established r/r lbcl; 2. patients already treated with commercially available relmacabtagene autoleucel exclusion criteria: no

Keywords: relmacabtagene autoleucel chimeric antigen receptor t cells
step'n out: a multisite trial of collaborative behavioral management for drug-involved parolees

Conditions: Substance-Related Disorders

Summary: the main purpose of this study is to examine whether improved integration between the community supervision system and outpatient addiction treatment system can improve treatment adherence, drug use and public safety outcomes among drug-involved inmates re-entering the community.

the target population consists of male and female parolees with a history of substance abuse treatment who are at moderate-to-high-risk of recidivism. they will recruited from in the criminal justice system and/or transitional residential drug treatment within one or two months of release or at the time they first report for parole supervision. participants from six states (ky, or, ri, ct, va, de) will be randomized into the step'n out condition (integration of community supervision and addiction treatment with behavioral management) or a comparison condition including traditional community supervision and addiction treatment. research interviews at baseline, and 3 and 9 months after release from confinement will assess study participants' outcomes. the step'n out intervention will produce significantly better outcomes than the standard referral condition with respect to: recidivism rates (revocation, rearrest on a new charge, reconviction, reincarceration), as assessed 3 and 9 months after the end of the intervention; treatment participation (i.e., proportion of planned sessions attended, proportion of planned days retained in treatment, type of discharge \[successful completion, transfer to another program, elopement, administrative discharge, return to custody\], as assessed after the end of the intervention; self-reported drug use, criminal activity, and psychosocial functioning, as assessed 3 and 12 months after the end of the intervention; cost-effectiveness; collaboration between the supervision officer and treatment counselor ; and therapeutic alliance with the clients.

Eligibility criteria:
inclusion criteria: 1. be at least 18 years old and speak english; 2. have probable drug dependence immediately prior to incarceration as determined by a score of 3 or higher on the tcu drug screen ii; 3. be at moderate-to-high-risk of drug relapse and/or recidivism as determined by a lifestyle criminality screening form (lcsf) score of 7 or greater, or a history of 2 or greater prior treatments for drug-related problems or drug-related convictions; 4. must have substance use treatment as a mandated or recommended condition of parole. exclusion criteria: 1. psychotic features; 2. parole or probation conditions that prohibit them from participating in the protocol.

Keywords: substance-related disorders prisoners
a phase i safety and immunogenicity trial of ubi synvac (hiv-1 mn octameric v3 peptide vaccine)

Conditions: HIV Infections

Summary: to determine the safety, immunogenicity, and optimal dose of rgp120/hiv-1mn octameric v3 peptide vaccine (synvac) in healthy volunteers. it is likely that the ultimate control of aids will depend on the development of safe and effective vaccines against hiv-1. synvac is a synthetic candidate vaccine based on eight v3-derived peptides attached to a heptalysyl core to form radial octamers. in animal studies, the vaccine appears safe and demonstrates the capability for producing immune responses.

it is likely that the ultimate control of aids will depend on the development of safe and effective vaccines against hiv-1. synvac is a synthetic candidate vaccine based on eight v3-derived peptides attached to a heptalysyl core to form radial octamers. in animal studies, the vaccine appears safe and demonstrates the capability for producing immune responses. twelve volunteers are entered at one of three dose levels of synvac. at each dose level, 10 volunteers receive vaccine and two receive placebo. at least eight volunteers at each dose level must be monitored for 1 week before subsequent volunteers are entered at the next higher level. intramuscular injections are given on day 0, 28, and 168. approximately 12 clinic visits are required.

Eligibility criteria:
inclusion criteria subjects must have: * normal history and physical exam. * negative for hiv by elisa within 6 weeks of immunization. * cd4 count \>= 400 cells/mm3. * normal urinalysis. exclusion criteria co-existing condition: subjects with the following conditions are excluded: * medical or psychiatric condition or occupational responsibilities that preclude compliance. * active syphilis (volunteers are eligible if serology is documented to be a false positive or due to a remote (\> 6 months) treated infection). * active tuberculosis (volunteers with a positive ppd and normal chest x-ray showing no evidence of tb and not requiring inh therapy are eligible). * hepatitis b surface antigenemia. subjects with the following prior conditions are excluded: * history of immunodeficiency, chronic illness, autoimmune disease, or use of immunosuppressive medications. * history of anaphylaxis or other serious adverse reactions to vaccines. prior medication: excluded: * live attenuated vaccines within the past 60 days. note: medically indicated subunit or killed vaccines (e.g., influenza, pneumococcal) are permitted if received at least 2 weeks prior to first immunization. * experimental agents within the past 30 days. * prior hiv vaccines. prior treatment: excluded: * blood products or immunoglobulin within the past 6 months. identifiable high-risk behavior for hiv infection, including history of injection drug use within the last 12 months prior to enrollment and higher or intermediate risk sexual behavior.

Keywords: vaccines, synthetic hiv-1 hiv envelope protein gp120 aids vaccines hiv seronegativity hiv preventive vaccine
water exercise and health (wathealth)

Conditions: Overweight; Hunger

Summary: aquatic cycling is becoming more popular as it appears to be more suitable for men and women even with poor physical activity level. commercial tagline highlight beneficial effect of this activity on weight management. however there are poor information concerning the energy response induced by this activity. the aim of this project is to investigate effect of water temperature on energetic response (energy expenditure and food intake) of cycling exercise in water in normal weight and overweight premenopausal women.

after inclusion visit, all subject will be submitted to dxa to obtain body composition data. then subjects will be submitted to four experimental session in a semi-randomized order. for all those session, subjects will take a standardized breakfast (570kcal) three hours before experimental session. control session (con): subject will stand sited without any activity during 40 min. subjects will be submitted to three aquatic cycling exercise session: * session 27°c :aquatic cycling at 27°c without water jet during 40 min * session 27°c+ water jets : aquatic cycling at 27 °c with water jets during 40 min * session 18°c : aquatic cycling at 187°c without water jet during 40 min every exercise session will be set at 70% of theorical maximal heart rate during each session, oxygen consumption and carbon dioxide production will be analysed with gas analysis system. appetite and hunger sensation will be measured with a specific scale at different time point of each day of experimental session. thirty minutes after the end of each experimental session subjects will have a buffet meal for lunch time.

Eligibility criteria:
inclusion criteria: * women aged between 20 and 40 years * bmi under 25kg.m2 for normal weight women and between 25 and 29,9 kg.m2 for overweight women * daily breakfast * subject which approved informed consent * subject with french medical affiliation exclusion criteria: * specific medical treatment * aquaphobia * subject under specific diet regimen or weight loss program * subject with cardio-vascular disease * surgical intervention less than 3 months * subject refusing informed and written consent * subject without french medical affiliation * subject refusing inscription to the national voluntary list * subject being in an exclusion period * subject smoking or drinking alcohol frequently * subject with intense physical activity

Keywords: energy expenditure food intake women aquacycling
low anterior resection syndrome and rectal irrigation study

Conditions: Anterior Resection Syndrome

Summary: prospective study assessing treatment acceptability and the impact of rectal irrigation on patients with low anterior resection syndrome (lars) in terms of quality of life and bowel function.

aims: to assess if rectal irrigation improves patient symptoms and quality of life in patients with lars and to see if the treatment is acceptable to patients. methods: this is a mixed methods evaluation study on functional outcomes in patients who have undergone anterior resection for rectal neoplasia and who have had bowel continuity restored between jan 2009 and jan 2014. those patients deemed to have lars who consent to participation in the study will be offered rectal irrigation.

Eligibility criteria:
inclusion criteria: * patients who have undergone anterior resection for rectal neoplasia, patients who have had restored bowel continuity * lars score of \>20 (defined lars syndrome) * patients \> 18 years of age. exclusion criteria: * previous use of rectal irrigation * patients who are unable to give informed consent * patients who are not physically capable of performing the treatment in their home
pegylated somatropin (peg somatropin) in the treatment of children with growth hormone deficiency

Conditions: Growth Hormone Deficiency

Summary: to evaluate the safety and efficacy of peg somatropin injection in the treatment of children with growth hormone deficiency, as well as to study the feasibility of extending the dosing intervals (once per two weeks) of peg somatropin injection.


Eligibility criteria:
inclusion criteria: * subjects are diagnosed as ghd before starting treatment, according to medical history, clinical symptoms and signs, gh provocation tests and imaging and other examinations: 1. according to statistical height data of physical development of chinese children in nine cities in 2005, the height is lower than 3rd percentile growth curve of the same age, same sex normal children; 2. height velocity (hv) ≤5.0 cm / yr; 3. gh provocative tests (with two drugs of different mechanism of action) confirmed plasma gh peak \<10.0 ng / ml; 4. bone age for girl≤9 years old, for boy≤10 years old, bone age is one year or more later than the actual age, that is the actual age - bone age ≥ 1 year; * before puberty (tanner i stage), age≥3 years old, male or female; * subjects have not received hormone therapy within 6 months; * subjects is willing and able to cooperate to complete scheduled visits, treatment plans and laboratory tests and other procedures, to sign informed consent. exclusion criteria: * dysfunction of liver and kidney (alt\> 2 times the upper limit of normal, cr\> upper limit of normal); * patients positive for hepatitis b c-antibody (hbcab), hepatitis b surface antigen (hbsag) or hepatitis b e antigen (hbeag); * patients with known hypersensitivity to peg somatropin or somatropin or any other components of the study product; * patients with severe cardiopulmonary or hematological diseases, a current or past history of malignant tumors, immunodeficiency diseases, or mental diseases; * potential cancer patients (family history); * patients with diabetics; * patients with other growth disorders, such as turner's syndrome, sexual physical delayed puberty, laron syndrome, growth hormone receptor deficiency, girls with slowly growing who did not rule out chromosomal abnormalities; * patients with congenital bone dysplasia or scoliosis; * subjects took part in other clinical trial study during 3 months; * other conditions in which the investigator preclude enrollment into the study.
process optimization of preoperative biliary drainage in patients with malignant obstructive jaundice

Conditions: Jaundice, Obstructive; Klatskin Tumor

Summary: the purpose of this study is to evaluate the safety and effectiveness of different methods of preoperative biliary drainage in patients with extrahepatic bile duct neoplasms with obstructive jaundice (hilar cholangiocarcinoma, distal bile duct cancer, and periampullary carcinoma), including ptbd (percutaneous transhepatic biliary drainage), enbd (endoscopic nasobiliary drainage) and ebs (endoscopic biliary stenting).


Eligibility criteria:
inclusion criteria: * patients who meet the following four criteria are included into the study: 1. preoperative clinical diagnosis of hilar cholangiocarcinoma, distal bile duct cancer, periampullary cancer without distant metastasis or peripheral vascular invasion, and plan for radical surgery; 2. serum total bilirubin is higher than 51 umol/l; 3. age is older than 18 and younger than 80 years old; 4. sign in informed consent to receive preoperative ptbd, enbd, ebs or without pbd. exclusion criteria: * if any of the following items are met, the subject cannot enter the study. 1. incorporate severe mental illness, severe heart, lungs and kidneys disease, etc., and be unable to tolerate surgery; 2. malignant obstructive jaundice caused by metastatic tumors; 3. pregnancy or lactation women.
the diagnostic value of staging laparoscopy and computed tomography response assessment in patients with gastric adenocarcinoma

Conditions: Gastric Cancer

Summary: summary rationale: diagnostic laparoscopy (dl) and response assessment after neoadjuvant chemotherapy with computed tomography (ct) are two diagnostic modalities used to assess metastatic spread in gastric cancer patients. it is still unclear in what proportion of patients clinically relevant metastases or other significant findings (e.g. contra-indications of surgery) are detected that impact on the treatment. objective: to determine the clinical value of diagnostic laparoscopy and computed tomography response assessment after neoadjuvant chemotherapy in patients with gastric and esophagogastric junction adenocarcinoma. study design: multicentre retrospective cohort study. study population: all patients with gastric and gastro-oesophageal adenocarcinoma who underwent clinical staging and were discussed at multidisciplinary team meetings (mdt) between january 2016 and december 2018. intervention (if applicable): not applicable. main study parameters/endpoints: the main study parameter is the proportion (%) of patients who do not proceed with treatment as planned after a dl and ct response assessment (i.e. the proportion of patients in which metastasized disease or other contra-indications for surgery is found). nature and extent of the burden and risks associated with participation, benefit and group relatedness: since this is an observational study, no burden or risks are associated with participation.


Eligibility criteria:
inclusion criteria: * patients with histologically proven gastric and esophagogastric junction adenocarcinoma. * patients who have had (either) dls and/or ct response assessment (after chemotherapy). * discussed at mdt from january 2016 - december 2018 * ≥18 years exclusion criteria: * patients with esophagogastric junction adenocarcinoma with the tumour bulk located in the oesophagus that receive neoadjuvant chemoradiation; * patients with recurrent/residual disease after earlier treatment of gastric cancer.
study of dn-101 (calcitriol) and docetaxel in subjects previously enrolled in studies dn101-002 or dn101-004

Conditions: Androgen Independent Prostate Cancer (AIPC); Non Small Cell Lung Cancer (NSCLC)

Summary: the purpose of this study is to monitor the safety of continued dn-101 and docetaxel treatment for subjects previously enrolled in dn101-002 (ascent) or dn101-004 (nsclc) studies.

this is a multicenter, open-label trial of dn-101 and docetaxel combination therapy to monitor the safety of ongoing dn-101 and docetaxel treatment for subjects previously enrolled in dn101-002 or dn101-004 studies. for subjects enrolled in dn101-002 study, only subjects randomized to the dn-101 treatment arm and are currently receiving study drug (including subjects on study suspension / holiday) will be included in the current study. for subjects enrolled in dn101-004 study, only subjects who are receiving study treatment will be included. safety will be assessed throughout the study. safety evaluations will consist of a modified physical exam (vital signs and weight) and laboratory assessments. modified physical exam should be performed at the beginning of each treatment cycle. docetaxel-related laboratory assessments will be performed per standard of care as noted in the labeling. dn-101-related laboratory assessments for serum calcium and serum creatinine will be performed at the beginning of each treatment cycle. clinically significant abnormal laboratory values will be reported as adverse events.

Eligibility criteria:
inclusion criteria: * prior participation in dn101-002 or dn101-004 studies, where the subject received at least one dose of dn-101 * able and willing to give written informed consent exclusion criteria: * disease progression or unacceptable toxicity while previously enrolled in dn101-002 or dn101-004 studies * prior investigational therapy other than dn-101 within 30 days of enrollment * known hypersensitivity to calcitriol * pregnancy (women of childbearing potential only) * greater than 90 days has elapsed from termination of dn101-002 or dn101-004 studies

Keywords: calcitriol, dn-101, androgen independent prostate cancer (aipc), prostate cancer, non small cell lung cancer (nsclc)
11c-choline pet/ct and dwi mri for response assessment of hcc candidate to tare

Conditions: Hepatocarcinoma

Summary: prospective exploratory study specifically investigating the diagnostic and predictive role of 11c-choline pet/ct and dwi mri for response assessment in patients affected by hcc and candidate to tare. a minimum number of 20 patients will be considered for the analysis.

for the study, all patients with a histological diagnosis of hcc and eligible for tare, i.e. with liver predominant disease who are not eligible for curative surgery, after multidisciplinary discussion will be included. in all cases, patients will undergo 11c-choline pet/ct and dwi mri before starting radioembolization and will be subsequently restaged 3 months after treatment completion. a minimum number of 20 patients will be considered for the analysis.

Eligibility criteria:
inclusion criteria: * patients with a histological diagnosis of hcc and eligible for tare, i.e. with liver predominant disease who are not eligible for curative surgery, after multidisciplinary discussion will be included; * obtained informed consent exclusion criteria: * patients age \<18 years * pregnancy or breast-feeding; * patients affected by other malignancies within the last 3 years; * disseminated extrahepatic disease; * severely abnormal excretory liver function tests or ascites suggestive of liver failure; * hepatopulmonary shunt \>20%; * vascular variants and abnormalities as demonstrated on pre-treatment angiography, which cannot be corrected by embolisation and which lead to reflux of hepatic arterial blood to the stomach, pancreas or bowel.

Keywords: hepatocarcinoma tare response assessment